Enablex

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INDICATIONS

DOSAGE AND ADMINISTRATION

The recommended starting dose of Enablex is 7.5 mg once
daily. Based upon individual response, the dose may be increased to 15 mg once
daily, as early as two weeks after starting therapy.

Enablex should be taken once daily with water. Enablex may
be taken with or without food, and should be swallowed whole and not chewed,
divided or crushed.

For patients with moderate hepatic impairment (Child-Pugh B)
or when co-administered with potent CYP3A4 inhibitors (for example,
ketoconazole, itraconazole, ritonavir, nelfinavir, clarithromycin and
nefazadone), the daily dose of Enablex should not exceed 7.5 mg. Enablex is not
recommended for use in patients with severe hepatic impairment (Child-Pugh C) [see
WARNINGS AND PRECAUTIONS, DRUG INTERACTIONS, Use in Specific
Populations and CLINICAL PHARMACOLOGY].

HOW SUPPLIED

Dosage Forms And Strengths

Enablex extended-release tablets 7.5 mg are round, shallow,
bi-convex, white-colored tablets, and are identified with “DF” on one side and
“7.5” on the reverse.

Enablex extended-release tablets 15 mg are round, shallow,
bi-convex, light peach-colored tablets, and are identified with “DF” on one
side and “15” on the reverse.

Storage And Handling

Enablex®,7.5 mg are round, shallow, bi-convex,
white-colored tablets, and are identified with “DF” on one side and “7.5” on
the reverse.